Catheter with integrated cement delivery balloon

ABSTRACT

A bone filling device includes a catheter that defines a longitudinal axis and extends between a proximal end and a distal end. A first lumen extends along the longitudinal axis of the catheter and defines a first passageway. A second lumen extends along the longitudinal axis of the catheter and defines a second passageway. An inflatable body includes a wall that defines a fillable cavity. The fillable cavity is in fluid communication with the first passageway. A bone filler delivery port is continuous with the second passageway and is configured to dispense bone filling material.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal structures, and more particularly to asurgical system and method employing a cement delivery system and aninflatable balloon.

BACKGROUND

Extremity fractures of a calcaneus or other bone may be reducedpercutaneously using Inflatable Bone Tamps (IBTs). While effective, IBTsare typically designed for the spine and the lifting of vertebralbodies. The inflation profiles of these balloons are most effective atlifting flat surfaces. However, calcaneus fractures typically occur onthe superior, anterior portion of the bone, which normally has an angledorientation. A single IBT is typically not sufficient to reorient thesurface satisfactorily. Many times, multiple balloons are required toreturn the calcaneus surface to a proper orientation. This disclosuredescribes an improvement over these prior art technologies.

Bone filling material is often used with IBTs, however the IBTs wouldneed to be deflated and removed before bone filling material such asbone cement can be deployed. With the removal of the IBT, often heightrestoration is lost. Thus, what is needed is a device that would allowbone cement delivery while maintaining height restoration.

SUMMARY

Accordingly, a bone filling device includes a catheter that defines alongitudinal axis and extends between a proximal end and a distal end. Afirst lumen extends along the longitudinal axis of the catheter anddefines a first passageway. A second lumen extends along thelongitudinal axis of the catheter and defines a second passageway. Aninflatable body includes a wall that defines a fillable cavity. Thefillable cavity is in fluid communication with the first passageway. Abone filler delivery port continuous with the second passageway andconfigured to dispense bone filling material. The device is configuredfor insertion through a cannula into tissue.

A method of filling bone comprising inserting a cannula into bone.Inserting a catheter into the cannula. The catheter defines alongitudinal axis and extends between a proximal end and a distal endand includes a first lumen extending along the longitudinal axis of thecatheter and defines a first passageway. A second lumen extending alongthe longitudinal axis of the catheter and defines a second passageway.An inflatable body having a wall that defines a fillable cavity. Thefillable cavity is in fluid communication with the first passageway. Abone filler delivery port continuous with the second passageway andconfigured to dispense bone filling material. Inflating the balloon suchthat the balloon applies a force capable of compacting cancellous boneand moving fractured bone. Inserting a bone filler delivery port throughthe passageway and delivering a bolus of bone filler material while theballoon is inflated. Removing the bone filler delivery port. Allowingfor the bone filler material to cure such it forms a shell of bonefiller material at the distal end of the balloon and is capable ofmaintaining a restored height to the bone and deflating and removing theballoon.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of one embodiment of components of acatheter system in accordance with the principles of the presentdisclosure;

FIG. 2 is a plan view of components of the system of FIG. 1 inaccordance with the principles of the present disclosure;

FIG. 3 is a plan view of components of the system of FIG. 1 inaccordance with the principles of the present disclosure;

FIG. 4 is a side view of components of the system of FIG. 1 inaccordance with the principles of the present disclosure;

FIG. 5 is a top view of components of the system of FIG. 1 in accordancewith the principles of the present disclosure;

FIG. 6 is a side perspective view of components of the system of FIG. 1in accordance with the principles of the present disclosure; and

FIG. 7 is a side view of components of the system of FIG. 1 disposedwith calcaneus bone in a heel.

Like reference numerals indicate similar parts throughout the figures.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system and method for bone repair. It is envisioned thatthe surgical system and method may be employed in applications such asfor correction of fractures, depressions and breaks. For example, thesurgical system and method can include inflatable bone tamps (IBT)presenting an angled surface for the repair of bones.

In one embodiment, the system and method include an inflatable bone tampthat reduces the complexity of a procedure where a surface for a bonerepair needs an angled or curve IBT profile. The IBT has an angledsurface provided by employing a series of balloons, which form acomposite shape. The balloons may be formed from a compliant material toaid in removing the IBT after use. The composite shape of the IBTprovides a sufficient volume to reduce depressions or displaced bonetissues, which is less than conventional IBTs.

In kyphoplasty procedures surgeons find current devices lack the abilityto maintain vertebral body height restoration achieved by the balloononce the balloon is deflated and removed to insert a bone cementdelivery device. In one embodiment, a catheter is provided thatintegrates an inflatable balloon and a cement delivery device within thesingle catheter. The balloon is inflated to restore height to the bone.Once height restoration is achieved, a bone filling device is insertedand a small cement bolus is deployed at the distal end of the catheterwhile the balloon remains inflated. The cement cures and forms an eggshell-like structure around at least the front portion of the balloonwhich us sufficient to maintain the restored height. Once the cementcures enough to stabilize the height, the cement delivery device and theballoon are removed. The cavity can then be back filled with additionalbone cement as needed.

The cross section of the balloon catheter maximizes for cement deliveryand minimizes for saline or contrast delivery. To manufacture thedevice, approximately a centimeter of the catheter is trimmed to exposethe lumen inside the balloon. An adhesive, such as, for example, aUV-curing cement is used to adhere the balloon to the catheter. In oneembodiment, marker bands are provided on the catheter and/or balloon soas to help in determining the orientation of the device in situ.

The device of the present disclosure can be utilized for extremitiesuse, for filling metastatic lesions as well as other medical procedures.

It is contemplated that one or all of the components of the surgicalsystem may be disposable, peel-pack, pre-packed sterile devices. One orall of the components of the surgical system may be reusable. Thesurgical system may be configured as a kit with multiple sized andconfigured components.

It is envisioned that the present disclosure may be employed to treatbones, and in particular extremity bones such as the calcaneus. Itshould be understood that the present principles are applicable to anybone structures, including but not limited to bones of the spine, legs,feet, arms, etc. It is contemplated that the present disclosure may beemployed with other osteal and bone related applications, includingthose associated with diagnostics and therapeutics. It is furthercontemplated that the disclosed surgical system and methods mayalternatively be employed in a surgical treatment with a patient in aprone or supine position, and/or employ various surgical approaches,including anterior, posterior, posterior mid-line, direct lateral,postero-lateral, antero-lateral, etc. approaches in the calcaneus, spineor other body regions. The present disclosure may also be alternativelyemployed with procedures for treating the muscles, ligaments, tendons orany other body part. The system and methods of the present disclosuremay also be used on animals, bone models and other non-livingsubstrates, such as, for example, in training, testing anddemonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the disclosure taken in connectionwith the accompanying drawing figures, which form a part of thisdisclosure. It is to be understood that this disclosure is not limitedto the specific devices, methods, conditions or parameters describedand/or shown herein, and that the terminology used herein is for thepurpose of describing particular embodiments by way of example only andis not intended to be limiting of the claimed disclosure. Also, as usedin the specification and including the appended claims, the singularforms “a,” “an,” and “the” include the plural, and reference to aparticular numerical value includes at least that particular value,unless the context clearly dictates otherwise. Ranges may be expressedherein as from “about” or “approximately” one particular value and/or to“about” or “approximately” another particular value. When such a rangeis expressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), in an effort toalleviate signs or symptoms of the disease or condition. Alleviation canoccur prior to signs or symptoms of the disease or condition appearing,as well as after their appearance. Thus, treating or treatment includespreventing or prevention of disease or undesirable condition (e.g.,preventing the disease from occurring in a patient, who may bepredisposed to the disease but has not yet been diagnosed as having it).In addition, treating or treatment does not require complete alleviationof signs or symptoms, does not require a cure, and specifically includesprocedures that have only a marginal effect on the patient. Treatmentcan include inhibiting the disease, e.g., arresting its development, orrelieving the disease, e.g., causing regression of the disease. Forexample, treatment can include reducing acute or chronic inflammation;alleviating pain and mitigating and inducing re-growth of new ligament,bone and other tissues; as an adjunct in surgery; and/or any repairprocedure. Also, as used in the specification and including the appendedclaims, the term “tissue” includes soft tissue, ligaments, tendons,cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference will now be made in detail to the exemplaryembodiments of the present disclosure, which are illustrated in theaccompanying figures. Turning now to FIGS. 1-7, there are illustratedcomponents of a surgical system, such as, for example, a catheter system20 and embodiments in accordance with the principles of the presentdisclosure.

The components of catheter system 20 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites, depending on the particular application and/or preference ofa medical practitioner. For example, the components of catheter system20, individually or collectively, can be fabricated from materials suchas stainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,stainless steel alloys, superelastic metallic alloys (e.g., Nitinol,super elasto-plastic metals, such as GUM METAL® manufactured by ToyotaMaterial Incorporated of Japan), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™ manufactured by Biologix Inc.),thermoplastics such as polyaryletherketone (PAEK) includingpolyetheretherketone (PEEK), polyetherketoneketone (PEKK) andpolyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO₄ polymericrubbers, polyethylene terephthalate (PET), fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone materialincluding autograft, allograft, xenograft or transgenic cortical and/orcorticocancellous bone, and tissue growth or differentiation factors,partially resorbable materials, such as, for example, composites ofmetals and calcium-based ceramics, composites of PEEK and calcium basedceramics, composites of PEEK with resorbable polymers, totallyresorbable materials, such as, for example, calcium based ceramics suchas calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite(HA)-TCP, calcium sulfate, or other resorbable polymers such aspolyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe andtheir combinations. Various components of catheter system 20 may havematerial composites, including the above materials, to achieve variousdesired characteristics such as strength, rigidity, elasticity,compliance, biomechanical performance, durability and radiolucency orimaging preference. The components of catheter system 20, individuallyor collectively, may also be fabricated from a heterogeneous materialsuch as a combination of two or more of the above-described materials.The components of catheter system 20 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Catheter system 20 is employed, for example, with an open, mini-open orminimally invasive surgical technique to attach move or apply pressureto a bone fragment, fracture or surface, such as, in treating calcaneusfractures. As shown in FIG. 1, system 20 includes a catheter 22extending between a proximal end 24 and a distal end 26. Catheter 22defines a longitudinal axis L1. Catheter 22 includes an outer surface 28and an inner surface 30. It is contemplated that surfaces 28, 30 mayhave surface configurations such as, for example, smooth, rough,arcuate, undulating, dimpled and/or textured, according to therequirements of a particular application.

As shown in FIGS. 1-2, Catheter 22 includes a first lumen 32 and asecond lumen 34. Lumen 32 is disposed along outer surface 28. Lumen 32defines a first passageway 36 defining longitudinal axis L2 that extendsparallel to axis L1. It is contemplated that passageway 36 can extendalong axis L1, perpendicular to axis L1 or transverse to axis L1. Lumen32 is configured to inflate or deflate an inflatable body, discussedherein. Lumen 34 is disposed along inner surface 30 and defines a secondpassageway 38. Passageway 38 extends along axis L1. It is contemplatedthat passageway 36 can extend parallel to axis L1, perpendicular to axisL1 or transverse to axis L1. Lumen 34 is configured to receive a bonefilling device, such as, for example, a bone filling tube, as discussedherein.

System 20 includes an inflatable body, such as, for example, a balloon40. Balloon 40 includes a wall 42 configured to define a fillable cavity44. Wall 42 includes an inner surface 46 and an outer surface 48. Innersurface 46 forms cavity 44. Outer surface 48 is configured to engage andapply force to tissue, such as, for example, cancellous bone in atraumatized calcaneus bone. It is contemplated that surface 48 may havesurface configurations to enhance engagement such as, for example,smooth, rough, arcuate, undulating, dimpled and/or textured, accordingto the requirements of a particular application. It is envisioned thatall or only a portion of balloon 40 may have cross sectionconfigurations, such as, for example, oval, oblong, triangular, square,polygonal, irregular, uniform, non-uniform, offset, staggered, and/ortapered depending on a particular application. Balloon 20 is inconfigured to be in communication with lumen 32 such that passageway 36receives material to inflate and/or deflate balloon 40.

System 20 includes a material delivery port, such as, for example, abone filler delivery port 50 located at distal end 26. It iscontemplated that other materials such as, saline, contrast or water canbe deployed through port 50 in addition to or instead of the bonefilling material. Port 50 is continuous with the passageway 38 andconfigured to dispense bone filling material. In one embodiment, port 50is configured to receive a bone filler tube (not shown). The bone fillertube is inserted into passageway 38 such that an end of the bone fillertube extends out of port 50 and past distal end 26. In thisconfiguration, the bone filler tube dispenses bone filling material 54into a cavity C. In another embodiment, bone filling material 54 isdispensed through passageway 38 and out port 50 such that an actuatingmechanism, such as, for example, a syringe (not shown) is utilized topush bone filling material 54 through passageway, out distal end 26 andinto cavity C. A bolus of bone filler material 54 is deployed from port50 such that material 54 spreads over a portion of outer surface 48 ofballoon 40 or directly forward balloon 40 such that the bone fillermaterial 54 forms an eggshell-like shape around surface 48 or forward tothe surface. When material 54 cures and hardens, balloon 40 can bedeflated. The eggshell-like structure is configured to maintain theheight between the collapsed bone structures such that additionalmaterial 54 can be injected. The initial bolus of cement forming theeggshell-like structure that maintains the height as the balloon isdeflated and removed, blends with the additional cement added so as tocreate a continuous cement structure filling the void created by theballoon. It is important to deliver the additional cement while theeggshell-like structure is still hardening so that the additional cementhardens so as to be continuous with the cement forming the eggshell-likestructure.

System 20 further includes a cannula 56. Catheter 22 is configured forinsertion through cannula 56 and into tissue such that balloon 40 can beinflated and apply a force F capable of compacting cancellous bone andmoving fractured bone to restore height to the bone.

In assembly, operation and use, system 20 is employed with a surgicalprocedure, such as, for a correction or treatment of bone fractures. Itis contemplated that one or all of the components of system 20 can bedelivered or implanted as a pre-assembled device or can be assembled insitu.

For example, as shown in FIGS. 1-7, system 20, described above, can beemployed with a surgical correction treatment of an applicable conditionor injury of an affected portion of a, calcaneus bone, bones of the feetor hands, bones of the spine, bones of the arms and legs, etc. and otherareas within a body.

In use, to treat a fracture, a medical practitioner obtains access to asurgical site including the fractured bone in any appropriate manner,such as through incision and retraction of tissues. In one embodiment, adrill is employed to remove bone tissue to provide access to a repairsite. It is envisioned that system 20 can be used in any existingsurgical method or technique including open surgery, mini-open surgery,minimally invasive surgery and percutaneous surgical implantation,whereby the fractured or injured bone is accessed through amini-incision or sleeve that provides a protected passageway to thearea. Once access to the surgical site is obtained, the particularsurgical procedure can be performed for treating the injury or disorder.The configuration and dimension of system 20 is determined according tothe configuration, dimension and location of a selected section of thebone fracture and the requirements of a particular application.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for implantation of components ofsystem 20. This may include the use of a cannula or other device. Apreparation instrument (not shown) can be employed to prepare tissuesurfaces, as well as for aspiration and irrigation of a surgical regionaccording to the requirements of a particular surgical application.

Cannula 56 is inserted into the surgical pathway into cavity C locatedbetween fractured bones in a heel, as shown in FIG. 7. It iscontemplated that system 20 can be utilized with other areas of bonefractures such as vertebral, tibia or hip. Catheter system 20 isinserted through cannula 56. Balloon 40 is inflated by lumen 32 suchthat balloon expands into cavity C and wall 42 exerts a force F on thecancellous to restore the height h of the fractured bone, as shown inFIG. 7. When a desired height h is restored to the fractured bone, bonefilling material 54 is inserted through passageway 38, either via a tubeor a syringe, into port 50, either via a bone filling device or use of asyringe, while the balloon is still inflated. A bolus of bone fillermaterial 54 is deployed from port 50 such that material 54 spreads overa portion of outer surface 48 of balloon 40 or in the alternative justforward of the inflated balloon such that the bone filler material 54forms an eggshell-like shape around surface 48 or forward the balloon40. Once material 52 cures and hardens balloon 40 can be deflated. Theeggshell-like structure is configured to maintain height h between thebones such that when balloon 40 is removed height h remains the samesuch that no height restoration when the balloon is removed. Whenballoon 40 is removed, or in the alternative while the balloon 40 is inthe process of being deflated, the practitioner can further fill thecavity to build on the initial eggshell-like film to form a single massof bone filler to maintain bone height.

Other components of system 20 are delivered to the surgical site alongthe surgical pathway(s). In one embodiment, system 20 includes an agent,which may be disposed, packed or layered within, on or about thecomponents and/or surfaces of system 20. It is envisioned that the agentmay include bone growth promoting material, such as, for example, bonegraft to enhance fixation of the fixation elements with the bone in needof repair.

It is contemplated that the agent may include therapeuticpolynucleotides or polypeptides. It is further contemplated that theagent may include biocompatible materials, such as, for example,biocompatible metals and/or rigid polymers, such as, titanium elements,metal powders of titanium or titanium compositions, sterile bonematerials, such as allograft or xenograft materials, synthetic bonematerials such as coral and calcium compositions, such as HA, calciumphosphate and calcium sulfite, biologically active agents, for example,gradual release compositions such as by blending in a bioresorbablepolymer that releases the biologically active agent or agents in anappropriate time dependent fashion as the polymer degrades within thepatient. Suitable biologically active agents include, for example, BMP,Growth and Differentiation Factors proteins (GDF) and cytokines. Thecomponents of system 20 can be made of radiolucent materials such aspolymers. Radiomarkers may be included for identification under x-ray,fluoroscopy, CT or other imaging techniques. It is envisioned that theagent may include one or a plurality of therapeutic agents and/orpharmacological agents for release, including sustained release, totreat, for example, pain, inflammation and degeneration.

It is envisioned that the use of microsurgical and image guidedtechnologies may be employed to access, view and repair bonedeterioration or damage, with the aid of system 20. Upon completion ofthe procedure, the surgical instruments and assemblies are removed. Theopening drilled in to the bone is filled with a bone cement to providesupport for the repaired bone, and the incision is closed.

Additionally, balloons used in the medical device in accordance with thepresent disclosure can be single or multi-layered balloons where eachballoon layer has the same diameter and/or wall thickness, is comprisedof the same material or materials having substantially identicalmechanical properties, and has the same degree of molecular orientationin the body portion of the balloon. It will be apparent that in somesituations it will be desirable to have some balloon layers havingdifferent thicknesses, materials, and/or degree of molecularorientations upon deflation, while at the same time having equivalentsize, mechanical properties, and/or orientation upon inflation. Forother applications, it will be apparent that one can vary size,material, and/or orientation to at least some degree while stillremaining within the spirit of the invention.

In one aspect of the embodiments of the present disclosure, the balloonscan be adapted to withstand the particular stresses, pressures, anddeformities to which they might be placed under when inflated to returnthe calcaneus surface to a proper orientation. For example, because thetop layer might be exposed to sharp objects (such as calcified plaque,bone, bone spurs, or other natural protrusions within a patient's body),the top layer could be made from a more compliant material that isscratch and puncture resistant. In the case of a multi-layer balloon,the outer layer is made from a more compliant material that is scratchand puncture resistant and the inner layers of the multi-layer balloon,which are generally not exposed to sharp objects, made from a lesscompliant material with a higher burst strength. It will be apparentthat further variations are possible, depending on which stresses,pressures, and deformities the layers must withstand in a particularmedical application.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.The balloon can be modified or extended to accommodate particularformulations of balloon construction materials or fabricationtechniques. Different balloon materials and surface coatings, or outerlayers of different materials or surface coatings may also be applied tothe balloon to facilitate a smaller balloon profile, biocompatibility,lubrication as well as other properties.

The embodiments above can also be modified so that some features of oneembodiment are used with the features of another embodiment. One skilledin the art may find variations of these preferred embodiments, which,nevertheless, fall within the spirit of the present invention, whosescope is defined by the claims set forth below.

What is claimed is:
 1. A bone filling system comprising: a cannula; acatheter inserted through the cannula and comprising an outer surfaceand an inner surface that define a wall thickness of the catheter, thecatheter defining a longitudinal axis and extending between a proximalend and a distal end; a first lumen disposed within the wall thickness,the first lumen extending along the longitudinal axis and defining afirst passageway; a second lumen disposed along the inner surface, thesecond lumen extending along the longitudinal axis and defining a secondpassageway; an inflatable body adhered to the catheter with an adhesive,the inflatable body having a wall defining a fillable cavity, theinflatable body being disposed along the outer surface and spaced fromthe cannula such that a distal tip of the catheter extends outwardlyfrom a distal end surface of the inflatable body, wherein the fillablecavity is in fluid communication with the first passageway; and a bonefiller delivery port continuous with the second passageway andconfigured to dispense bone filling material.
 2. A bone filling systemas recited in claim 1 further comprising a bone filler tube configuredfor insertion into the second lumen so as to exit the bone fillerdelivery port to dispense bone filling material.
 3. A bone fillingsystem as recited in claim 1, wherein the first lumen is spaced apartfrom the second lumen.
 4. A bone filling system as recited in claim 1,wherein the first lumen terminates prior to the distal end of thecatheter and the second lumen opens external to the fillable cavity. 5.A bone filling system as recited in claim 1, wherein the first lumen isconfigured to inflate the inflatable body.
 6. A bone filling system asrecited in claim 1, wherein the inflatable body is configured to inflateand apply a force capable of compacting cancellous bone and movingfractured bone.
 7. A bone filling system as recited in claim 1, whereinthe inflatable body comprises radio opaque markers to determineorientation of the inflatable body in situ.
 8. A bone filling system asrecited in claim 1, wherein the first lumen extends along a secondlongitudinal axis and the second lumen extends along a thirdlongitudinal axis that is offset from the second longitudinal axis.
 9. Abone filling system as recited in claim 8, wherein the second and thirdlongitudinal axes each extend parallel to the longitudinal axis of thecatheter.
 10. A bone filling system as recited in claim 1, wherein thefirst lumen extends along a second longitudinal axis and the secondlumen extends along a third longitudinal axis that is offset from thesecond longitudinal axis, the third longitudinal axis being coaxial withthe longitudinal axis of the catheter.
 11. A bone filling system asrecited in claim 1, wherein the catheter is monolithic.
 12. A bonefilling system as recited in claim 1, wherein the bone filler deliveryport is coaxial with the longitudinal axis and extends through a distalend surface of the catheter that extends transverse to the longitudinalaxis.
 13. A bone filling system as recited in claim 1, wherein theadhesive is a UV-curing cement.
 14. A bone filling system as recited inclaim 1, wherein the inflatable body comprises an outer layer made froma compliant material that is scratch and puncture resistant and an innerlayer made from a less compliant material with a higher burst strength,an inner surface of the inner layer defining the inflatable cavity. 15.A bone filling system comprising: a cannula; a bone filling deviceincluding a catheter defining a longitudinal axis and extending betweena proximal end and a distal end, the catheter comprising an outersurface and an opposite inner surface that define a wall thickness ofthe catheter; a first lumen disposed within the wall thickness, thefirst lumen extending along the longitudinal axis and defining a firstpassageway; a second lumen disposed along the inner surface, the secondlumen extending along the longitudinal axis and defining a secondpassageway; a balloon adhered to the catheter with an adhesive, theballoon having a wall defining a fillable cavity, the balloon beingdisposed along the outer surface and spaced from the cannula such that adistal tip of the catheter extends outwardly from a distal end surfaceof the balloon, wherein the fillable cavity is in fluid communicationwith the first passageway; and a bone filler delivery port continuouswith the second passageway and configured to dispense bone fillingmaterial, wherein the device is configured for insertion through thecannula into tissue such that the balloon is configured to inflate andapply a force capable of compacting cancellous bone and moving fracturedbone to restore height to the bone.
 16. A bone filling system as recitedin claim 15, wherein the first lumen terminates prior to the distal endof the catheter.
 17. A bone filling system as recited in claim 15,wherein the first lumen is configured to inflate the balloon.
 18. A bonefilling system as recited in claim 15, wherein the inflatable bodycomprises radio opaque markers to determine orientation of theinflatable body in situ.
 19. A bone filling system comprising: acannula; a catheter inserted through the cannula and comprising an outerand an inner surface that define a wall thickness of the catheter, thecatheter defining a longitudinal axis; a first lumen within the wallthickness, the first lumen extending along the longitudinal axis anddefining a first passageway; a second lumen disposed along the innersurface, the second lumen extending along the longitudinal axis anddefining a second passageway having a proximal end and a distal end; aballoon having a wall defining a fillable cavity, the balloon beingdisposed along the outer surface and spaced from the cannula such that adistal tip of the catheter extends outwardly from a distal end surfaceof the balloon, wherein the fillable cavity is in fluid communicationwith the first passageway, the balloon comprising an outer layer madefrom a compliant material that is scratch and puncture resistant and aninner layer made from a less compliant material with a higher burststrength; and a bone filler delivery port continuous with the secondpassageway and configured to dispense bone filling material, wherein thefirst lumen extends along a second longitudinal axis and the secondlumen extends along a third longitudinal axis that is offset from thesecond longitudinal axis.
 20. A bone filling system as recited in claim19, wherein the second passageway is configured so that bone fillermaterial can travel through the second passageway unobstructively andexit the second passageway through a port that is continuous with thesecond passageway.